From the Department of Gastroenterology and Hepatology, Sichuan University-University of Oxford Huaxi Joint Centre for Gastrointestinal Cancer, West China Hospital, Sichuan University, 37 Guoxue Ln, Chengdu 610041, China (X.W., G.L., J.W., X.X., Y.Y., Y.G., J.Y., L.Y., X. Luo); Department of Interventional Therapy, Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China (X. Li); and Department of Epidemiology and Medical Statistics, Department of Oncology, West China School of Public Health and West China Fourth Hospital, Sichuan University, Chengdu, China (Y.H.).
Radiology. 2023 Aug;308(2):e223201. doi: 10.1148/radiol.223201.
Background Some studies have shown that transjugular intrahepatic portosystemic shunt (TIPS) placement within 72 hours of admission improves survival in patients at high risk who present with acute variceal bleeding. However, the role of small-diameter covered TIPS in the secondary prophylaxis of variceal bleeding is still debatable. Purpose To compare the efficacy of 8-mm TIPS and endoscopic variceal ligation (EVL) plus propranolol in the prevention of variceal rebleeding among participants with advanced cirrhosis. Materials and Methods Between June 2015 and December 2018, participants admitted to the hospital for variceal bleeding were considered for enrollment in this randomized controlled trial (ClinicalTrials.gov). Participants with Child-Pugh class B or C cirrhosis were randomly assigned to receive an 8-mm covered TIPS or EVL and propranolol. The primary end point was recurrent variceal bleeding assessed using Kaplan-Meier curve analysis. Secondary end points included survival and overt hepatic encephalopathy (HE) assessed using Kaplan-Meier curve analysis. Results A total of 100 participants were enrolled, with 50 randomly assigned to the EVL plus propranolol group (median age, 54 years; IQR, 45-60 years; 29 male, 21 female) and 50 randomly assigned to the TIPS group (median age, 49 years; IQR, 43-56 years; 32 male, 18 female). The median follow-up period was 43.4 months. In the TIPS group, variceal rebleeding risk was reduced compared with variceal rebleeding risk in the EVL plus propranolol group (hazard ratio [HR], 0.31; 95% CI: 0.14, 0.69; = .008), but the incidence of overt HE was higher in the TIPS group (30.0% vs 16.0%, = .03). No differences in survival were observed between the two groups (1-year survival: TIPS, 98.0%; EVL plus propranolol, 92.0%; 3-year survival: TIPS, 94.0%; EVL plus propranolol, 85.7%; HR, 0.52; 95% CI: 0.19, 1.42; = .22). Conclusion When compared with EVL plus propranolol, 8-mm TIPS led to reduced variceal rebleeding but did not impact overall survival in participants with Child-Pugh class B or C cirrhosis. Clinical trial registration no. NCT02477384 © RSNA, 2023 See also the editorial by Barth in this issue.
背景 一些研究表明，在高危急性静脉曲张出血患者入院后 72 小时内进行经颈静脉肝内门体分流术（TIPS）可提高生存率。然而，小直径覆膜 TIPS 在静脉曲张出血二级预防中的作用仍存在争议。目的 比较 8mm TIPS 和内镜下套扎（EVL）加普萘洛尔在预防晚期肝硬化患者静脉曲张再出血中的疗效。材料与方法 2015 年 6 月至 2018 年 12 月，因静脉曲张出血入院的患者被考虑纳入这项随机对照试验（ClinicalTrials.gov）。Child-Pugh 分级为 B 或 C 级的患者被随机分配接受 8mm 覆膜 TIPS 或 EVL 加普萘洛尔治疗。主要终点是通过 Kaplan-Meier 曲线分析评估复发性静脉曲张出血。次要终点包括通过 Kaplan-Meier 曲线分析评估生存和显性肝性脑病（HE）。结果 共纳入 100 例患者，其中 50 例随机分配至 EVL 加普萘洛尔组（中位年龄 54 岁；IQR：45-60 岁；29 例男性，21 例女性），50 例随机分配至 TIPS 组（中位年龄 49 岁；IQR：43-56 岁；32 例男性，18 例女性）。中位随访时间为 43.4 个月。TIPS 组静脉曲张再出血风险低于 EVL 加普萘洛尔组（风险比 [HR]，0.31；95%CI：0.14，0.69； =.008），但 TIPS 组显性 HE 发生率较高（30.0% vs 16.0%， =.03）。两组的生存率无差异（1 年生存率：TIPS 组为 98.0%，EVL 加普萘洛尔组为 92.0%；3 年生存率：TIPS 组为 94.0%，EVL 加普萘洛尔组为 85.7%；HR，0.52；95%CI：0.19，1.42； =.22）。结论 与 EVL 加普萘洛尔相比，8mm TIPS 可降低静脉曲张再出血率，但对 Child-Pugh 分级为 B 或 C 级的肝硬化患者的总体生存率无影响。临床试验注册号 NCT02477384 © RSNA，2023 参见本期 Barth 的社论。
